Comparison of Medical Nutritional Supplements

NCT01483976 | Completed Phase 3 DMC

• 1 other identifier: BK96
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.

Conditions

Elderly

Outcome Measures

Primary Outcomes (1)

• Change in protein metabolism

  Via amino acid tracers

  Between baseline and 8 hours later

Secondary Outcomes (1)

• Intracellular signaling pathway metabolism

  Between Baseline and 8 hours later

Study Arms (2)

Oral medical nutritional supplement without AN777

ACTIVE COMPARATOR

orally over a three hour period

Other: Oral medical nutritional supplement

Experimental oral medical nutritional supplement with AN777

EXPERIMENTAL

orally over a three hour period

Other: Experimental oral medical nutritional supplement with AN777

Interventions

Oral medical nutritional supplement OTHER

orally over a three hour period

Oral medical nutritional supplement without AN777

Experimental oral medical nutritional supplement with AN777 OTHER

orally over a three hour period

Experimental oral medical nutritional supplement with AN777

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and is ≥ 60 and ≤ 90 years of age.
• Body Mass Index (BMI) \> 20.0, but \< 35.0.
• Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
• Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
• Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
• Refrain from intense physical activity between visits.

You may not qualify if:

• Systemic corticosteroids within the 3 months prior to enrollment.
• Blood thinner or anticoagulant medication within 1 week prior to enrollment.
• Glomerular filtration rate (eGFR) of \< 40 mL/min/1.73m2.
• Antibiotics within 1 week prior to enrollment.
• Major surgery less than 3 months prior to enrollment in the study.
• Active malignant disease or treated within the last 6 months for cancer.
• Immunodeficiency disorder.
• Diabetes
• Myocardial infarction 3 months prior to enrollment.
• Chronic obstructive pulmonary disease
• History of allergy to any of the ingredients in the study products.
• Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
• Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
• Pursuing weight loss or weight gain.
• Medications/dietary supplements/substances that could modulate metabolism or weight.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Study Officials

• Vikkie Mustad, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: December 2, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (1)